Virtual Reality Animation and Ice Massage on The Hoku Point
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ice massage
virtual reality animation
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring birth pain,, satisfaction, ice massage, virtual reality
Eligibility Criteria
Inclusion Criteria: Term primiparous and singleton pregnancies, Longitudinal and vertex position of the fetus, Body Mass Index (BMI) below 30, cervical dilatation of 0-3 cm, who agreed to participate in the study Exclusion Criteria: applying pharmacological intervention during labor, having a risky pregnancy, want to withdraw from the study, having ice allergy, being visually impaired.
Sites / Locations
- Kastamonu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
ice massage
virtual animation
Control Group
Arm Description
ice massage to hoku point for labor pain for 20 minutes
watching virtual animation for 20 minutes for labor pain
receiving standart care
Outcomes
Primary Outcome Measures
labor pain
Visual Analogue Scale (VAS)I
labor duration
Personal Information Form
labor duration
Personal Information Form
labor duration
Personal Information Form
birth satisfaction
Birth Satisfaction Scale - Revised (BSS-R)
labor pain
Visual Analogue Scale (VAS) II
labor duration
Personal Information Form
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850624
Brief Title
Virtual Reality Animation and Ice Massage on The Hoku Point
Official Title
Effect of Virtual Reality Animation and Ice Massage on The Hoku Point on Labor Pain, Duration of Labor, and Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study was to compare the effects of ice massage and virtual reality animation on labor pain, duration, and satisfaction with delivery.
The main questions aims to answer are:
H1 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor pain.
H2 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor duration.
H3 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' satisfaction.
This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test, chi-square test, Tukey's honestly significant difference test, and will used for data analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
birth pain,, satisfaction, ice massage, virtual reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ice massage
Arm Type
Experimental
Arm Description
ice massage to hoku point for labor pain for 20 minutes
Arm Title
virtual animation
Arm Type
Experimental
Arm Description
watching virtual animation for 20 minutes for labor pain
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
receiving standart care
Intervention Type
Other
Intervention Name(s)
ice massage
Other Intervention Name(s)
supportive care
Intervention Description
active phase when cervical dilatation was 6-8 cm. Ice will apply to the huko point (LI4 area) which is located on the dorsum of the hand, between the first and second metacarpal bones, between the thumb and the index finger for 20 minutes with an ice pack
Intervention Type
Other
Intervention Name(s)
virtual reality animation
Other Intervention Name(s)
supportive care
Intervention Description
cervical dilatation was 6-8 cm. Immediately after the second VAS application, the women will be asked about the video they wanted to watch of the sound of waves in the Ocean, rain falling or blooming trees with virtual reality glass. animation will show for a total of 20 min.
Primary Outcome Measure Information:
Title
labor pain
Description
Visual Analogue Scale (VAS)I
Time Frame
"Change from Baseline cervical dilatation 0-3 cm (duration can change 8-9 hours)
Title
labor duration
Description
Personal Information Form
Time Frame
"Change from Baseline cervical dilatation 6-8 cm(duration can change 4-8 hours)
Title
labor duration
Description
Personal Information Form
Time Frame
hour of latent phase ( duration can change 8-9 hour)
Title
labor duration
Description
Personal Information Form
Time Frame
hour of placental expulsion (duration can change 10 minutes to 30 minutes)
Title
birth satisfaction
Description
Birth Satisfaction Scale - Revised (BSS-R)
Time Frame
postpartum period up to 24 hours
Title
labor pain
Description
Visual Analogue Scale (VAS) II
Time Frame
active phase up to 20 hours
Title
labor duration
Description
Personal Information Form
Time Frame
hour of total delivery (can change 14-18 hours)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Term primiparous and singleton pregnancies,
Longitudinal and vertex position of the fetus,
Body Mass Index (BMI) below 30,
cervical dilatation of 0-3 cm,
who agreed to participate in the study
Exclusion Criteria:
applying pharmacological intervention during labor,
having a risky pregnancy,
want to withdraw from the study,
having ice allergy,
being visually impaired.
Facility Information:
Facility Name
Kastamonu University
City
Kastamonu
ZIP/Postal Code
37150
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I do not want to make individual participant data (IPD) available to other researchers.
Learn more about this trial
Virtual Reality Animation and Ice Massage on The Hoku Point
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